Job description: Description:PE Global is currently recruiting for an Operations Lead on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.Overview:
Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projects. This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.
They will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations.
They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.
Role Responsibilities:
Function as the site interface between the Product Delivery Teams (PDT’s), and Manufacturing operations.
Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.
Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection
Develop, review and update Production, Engineering, Operating Procedures & training materials
Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing
Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data
Provide troubleshooting support throughout the project and on the floor during execution of activities
Hold people to account for delivery and behaviors within the Manufacturing Support team and associated with the project(s)
Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects
Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences
Develop, review and update Protocols for manufacturing activities
Documentation and approval of protocol deviations for manufacturing activities
Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner
Own and lead change controls as required by the Manufacturing support team
Review and approve Bills of Materials
Develop, review and update Product Quality Risk Assessments
Skills required:
Bachelor’s degree in a science discipline.
3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.
Strong Project Management and organizational skills, including ability to follow assignments through to completion
Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity
Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
Interested candidates should submit an updated CV.Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Expected salary:
Location: Dublin
Job date: Tue, 03 Jun 2025 05:07:15 GMT
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